Medical records are currently prepared and stored by hand in physical files, by machine and converted to physical form through print outs for storage in physical files, or by machine and stored in digital form. The typical arrangement is to use all of these means in a complex mixture within a medical facility.
The normal evolution of digital medical record preparation and storage has been within a particular doctor's practice, clinic or hospital facilities grouping. With the advent of managed care networks, proprietary systems for providing network access to the data have been built, however, no large area, multi-institution, national or international medical repository has yet been built.
There are several reasons for the lack of a centralized database. First is the importance of maintaining the privacy of data. It is also difficult to exchange data between proprietary systems which code the same types of data differently. Another problem arises from the fact that different medical establishments store some data in digital exchangeable form and other data in less portable forms (paper and film); there is currently no universal agreement as to which data is stored in what form.
Medical establishments also gain a high degree of proprietary ownership of the patient when they retain the patient's medical information, even through they typically exchange data with each other when specifically requested to do so by the patient.
The primary efforts to implement a universal standard for medical data exchange have been driven by standards organizations. One example is the Andover Group, a non-profit organization which was originally organized by Hewlett Packard, but has since been joined by several hundred other organizations and companies. Andover Group has not defined standards for interoperation, but rather has endorsed existing standards. These are principally DICOM, an ISO standard for encoding medical image data, IEEE 1073, a networking and protocol standard for collecting and transmitting clinical observation data (such as from EKG or vital signs instruments), and HL7, an encoding method for patient medical records which include billings data and chart data.
Another example is the IEEE 1073 standards organization, which is organized to define an IEEE standard for networking and protocols for collecting and transmitting clinical observation data (such as from EKG or vital signs instruments). This group was formed in 1985 when many efforts to define application-specific alternatives to IEEE 802.3, or Ethernet, were prevalent. The 1073 committee took this route in the medical field, citing that normal Ethernet did not deliver predictable data delivery timing (because it uses collision detect multiple access to media allocation), and did not provide proper interconnect for use in the medical field (which included instrument isolation, quick connect, disconnect, and star configuration wiring). The 1073 committee has successfully defined 1073.1, the interconnect technology standard, but has to date failed to complete 1073.2 and up, which define standard protocols and encodings for clinical instrument data streams. Unfortunately, in 1999, Ethernet variations no longer have the cited interconnect limitations cited in 1985, which puts into doubt the value of 1073.1. Ethernet, in the 10 and 100 baseT configurations, allows quick connect/disconnect from star networks emanating from standard hubs (which are interconnects at the phone closet); wireless Ethernet adapters allow connections to local routers without any connection; and by using routers and gateways to connect instrument, room level, or unit level subnetworks, any degree of desired data delivery latency can be achieved. As it stands, 1073.1 may never gain widespread acceptance.
DICOM is an ISO standard which was defined to allow encoding and exchange of X-ray, CAT, and other digital image format data easily. Unfortunately, much medical imagery is still stored primarily on film, which must be physically copied and exchanged. Until the common X-ray machine is fully digital, this will remain the case.
HL7 is tagged object encoding formatted, defined for medical institutions to exchange medical records between dissimilar central computer systems. HL7 is gaining widespread acceptance as the main way for hospitals to exchange their data without paper files as the intermediary. This acceptance does not yet represent a majority of institutions. As indicated in the next paragraph, HL7 is by no means the only standard being considered.
CORBA, or Common Object Request Brokering Application, is a method defined and maintained by the Object Management Group (OMG). OMG acts as a clearing house for organizations building object oriented interoperable software/systems applications. OMG organizes standards committees much like the IEEE, ANSI, or ISO, but centered around object oriented programming methodology. CORBA is OMG's framework for all of these standards activities. Within the CORBA umbrella is the CORBAmed group. CORBAmed is focused on defining interoperable medical applications and standards which leverage the basic CORBA object oriented messaging and coding approach. CORBAmed has units which are concerned with defining interoperability with HL7 (and actually coding versions of HL7) within CORBA. CORBAmed is also currently defining Clinical Observation and Analysis Systems (COAS) using COBRA methods. Thus CORBAmed is very much a counter point to the Andover Group, IEEE 1073, and HL7. A similar effort at Microsoft to leverage COM, an alternative common object model has begun to address medical data management applications.
U.S. Pat. No. 5,778,882 to Raymond describes a system which tracks the health status of a patient by compiling a chronological multi-parameter health history from multiple sensors in contact with the patient's body. However, this system does not explain how the data is integrated with other types (for instance, image data or written patient record data such as billings or diagnosis events) or how the data is retained from previous procedures performed. Thus, this system misses the patient's whole life data recording, archival, and retrieval function.
U.S. Pat. No. 5,924,074 to Evans shows how text-type patient record data can be created and maintained electronically. This information includes complaints, lab orders, medications, diagnoses, and procedure descriptions. The description is of a specific implementation which appears to map directly on the structure described by documents associated with the definition of HL7, the standard for hospital and medical data record exchange. The key patented innovation is using pen-based portable computer interfaces. In this patent, we focus on presentation, data capture, and data integration for long term archival and retrieval. If the user prefers a portable user interface, a pen-portable computer would be appropriate, however, normal web-data terminal interfaces are usable as well.
U.S. Pat. No. 5,974,124 to Schlueter describes a system which assists doctors in treating patients with long term medical conditions. The system includes storage of medical data taken from the patient's body, presentable through the world wide web, however, does not address methods for dealing with multiple data types, protocols, or interfaces, and does not show how to incorporate paper based records. In addition, record keeping does not describe how the data will be maintained over the entire life of a patient.
U.S. Pat. No. 5,997,476 to Brown describes remote data collection, both in question answer form and data measurement form, for the purposes of transmission to the clinician and for subsequent display. This patent, however, does not describe how protocol, multiple data formats, and data archival are integrated together.
U.S. Pat. No. 6,032,119 to Brown describes display of individualized patient health status on a HTML display which depicts the human body. This is an interesting display method, but is limited to the specific integration of data required for the display coupled to its representation format. It does not describe archival or data collection specifically.
None of these standards efforts have addressed combining all medical data into a common database accessible or updateable from anywhere by anyone with appropriate access rights. Current methods do not teach how all forms of medical data from all sources are read in initially and updated routinely, nor do they explain how all forms of medical data from all sources are viewed and/or updated manually by patients, doctors, or other medical staff.